MAFAR4300 Development and Manufacturing of Medicinal Products Course description

This course concerns preclinical aspects of the development and manufacturing of medicinal products, with a particular focus on biological drugs and radiopharmaceuticals, which the pharmaceutical industry must consider before a pharmaceutical product becomes available to the user. Important topics include the choice of lead compounds, mode of action, choice of formulation and documentation of pharmaceutical quality.  

The student must have been admitted to the study programme.

After completing the course, the student should have the following overall learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can explain the structural elucidation and structure-activity relationship of various pharmaceutical candidates
• can discuss especially expedient production and formulation strategies for biologics and radiopharmaceuticals
• can explain relevant analytical methods and molecular engineering used in the development and production of biological drugs
• can explain the requirements that apply to documentation of pharmaceutical quality (FDA/EMA) in connection with  a marketing authorisation application

Skills

The student

• can critically assess and apply new knowledge about the structure-activity relationship of pharmaceuticals to develop new medicinal products
• can apply relevant legislation on quality assurance of the manufacturing, storage and distribution of medicinal products, with particular emphasis on biological drugs and radiopharmaceuticals
• can identify and elucidate the typical critical stages of the manufacturing and formulation of biological drugs and radiopharmaceuticals
• can apply methods for analysis and quality control of raw materials for biological drugs and radiopharmaceuticals, as well as ready-to-use medicinal products, and assess how deviations affect the quality of the final products

General competence

The student

• can contribute to quality development in the manufacturing of medicinal products
• can contribute to the process of developing a medicinal product until the finished product has been marketed and meet the medical needs of society, at the national and international level, in a sustainable manner

Work and teaching methods include lectures, student-active seminars, as well as project work and other group work. There will also be practical training in the laboratory. Discussions about the course content with fellow students and teachers is emphasised.

For the project work, the students will work in groups to assess relevant original articles related to drug development. 

The following must have been approved in order for the student to take the exam: 

• A minimum of 90 percent attendance at compulsory teaching activities
• Presentation of a project assignment in groups of 4-5 students

Students must have been admitted to the Master’s Programme in Health and Technology - Specialisation in Biomedicine.

After completing the course, the student should have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can explain the principles behind targeted and non-targeted analytical strategies in bioanalysis
• can describe advanced techniques for preparing biological matrices, including extraction and concentration techniques suitable for biological samples
• can describe the operation and applications of advanced analytical instruments, with emphasis on chromatographic and mass spectrometric techniques
• can explain quantitative analyses and calibration procedures used in bioanalysis, including the use of isotope-labelled standards, control samples and certified reference materials
• can explain procedures for identifying biomarkers, including data extraction, data processing and analysis of large amounts of analytical data
• can describe the principles for method development and validation in bioanalysis and the quality requirements that apply to such analyses

Skills

The student

• can make use of relevant literature as a basis for method development in bioanalysis
• can design proposals for analytical methods where independent choices of appropriate sample preparation and instrumental techniques need to be made
• can make use of different calibration techniques and associated quality control measures in quantitative analyses
• can perform biomarker identification based on chromatographic and mass spectrometric analyses
• can use statistical methods and statistical software to interpret and quality-test analysis results

General competence

The student

• can participate in quality assurance work and method development in the bioanalytical laboratory
• can contribute to the development of technology in the field
• has an overview of technology development and future perspectives in the field
• has insight into the applications and limitations of chromatographic and mass spectroscopic analytical techniques used in bioanalysis.

The work and teaching methods used include lectures, seminars with exercises, and skills training in the form of laboratory assignments. Digital learning resources will be made available to the students.

The following must have been approved in order for the student to take the exam:

• an assignment in groups of 2-4 students in the form of a case study with an oral presentation
• two laboratory projects with the submission of two lab reports based on specified criteria. The projects are carried out in groups of 2-4 students.

If the course is taught in English, the oral presentation of the case study must be given in English.

Supervised individual written exam, 3 hours.

The paper can be written in English or a Scandinavian language.